Assessment of Needs for a European Strategy on Exposure Science
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Assessment of Needs for a European Strategy on Exposure Science Summary Report of the first European Exposure Science Strategy Workshop: Building a Roadmap 2020-2030 Y. Bruinen de Bruin*, N. von Goetz, U. Schlüter, J. Bessems, A. Connolly, T. Dudzina, A. Ahrens, J. Bridges, M. Coggins, A. Conrad, A. Crépet, G. Heinemeyer, O. Hänninen, S. Kephalopoulos, M. McLachlan, T. Meijster, V. Poulsen, D. Rother, T. Vermeire, S. Viegas, J. Vlaanderen, M. Zare Jeddi, P. Fantke* *Corresponding authors 2019
Assessment of Needs for a European Strategy on Exposure Science ISES Europe 2018 Workshop Report Bruinen de Bruin Y.1*, von Goetz N.2, Schlüter U.3, Bessems J.4, Connolly A.5, Dudzina T.6, Ahrens A.7, Bridges J.8, Coggins M.9, Conrad A.10, Crépet A.11, Heinemeyer G.12, Hänninen O.13, Kephalopoulos S.14, McLachlan M.15, Meijster T.16, Poulsen V.17, Rother D.3, Vermeire T.18, Viegas S.19, Vlaanderen J.20, Zare Jeddi M.21, Fantke P.22* *Corresponding authors 1 DG Joint Research Centre, European Commission, Directorate E—Space, Security and Migration, Knowledge for Security and Migration Unit (E.7), Italy 2 Federal Office of Public Health, Switzerland 3 Federal Institute for Occupational Safety and Health (BAuA), Germany 4 VITO - Flemish Institute for Technological Research, Belgium 5 National University of Ireland Galway, Ireland 6 ExxonMobil, Belgium 7 European Chemicals Agency (ECHA), Finland 8 Emeritus Professor, University of Surrey, and Research for Sustainability, Guildford, United Kingdom 9 Academic Director MSc OESH, National University of Ireland, Galway, Ireland 19 German Environment Agency (Umweltbundesamt), Germany 11 French Agency for Health and Safety, France 12 Former Head of Unit, German Federal Institute for Risk Assessment, Germany 13 THL Public Health Solutions, Kuopio, Finland 14 DG Joint Research Centre, European Commission, Directorate F— Health, Consumers and Reference Materials, Knowledge for Health and Consumer Safety (F.7), Italy 15 Stockholm University, Sweden 16 Health and Safety Risk Management, Innovative technologies, Shell/ECETOC, The Netherlands 17 Head of Environmental Safety, L'Oréal, France 18 RIVM, National Institute for Public Health and the Environment, Netherlands 19 Escola Superior de Tecnologia da Saúde de Lisboa, ESTeSL-IPL, Portugal 20 Institute for Risk Assessment Sciences, Utrecht University, Netherlands 21 Division of Toxicology, Wageningen University and Research, Netherlands 22 Technical University of Denmark, Denmark This publication is a Technical report by the European Chapter of the International Society of Exposure Science (ISES Europe), which is a regional chapter of ISES. The objective of ISES Europe is to foster and advance exposure science needed to safeguard European citizens from environment-related pressures and risks for health and well-being. The contents of this report do not imply any position of the authors nor the listed institutions. Neither ISES Europe nor any person acting on behalf of ISES Europe nor the listed institutions are responsible for the use of this publication. For further information visit http://ises-europe.org/html/about.html (ISES Europe) or https://www.intlexposurescience.org (ISES). Contact information Name: Yuri Bruinen de Bruin | Peter Fantke E-mail: yuri.bruinen-de-bruin@ises-europe.org | peter.fantke@ises-europe.org ISES Europe Report http://ises-europe.org ISBN: 978-87-971147-0-4 © ISES Europe, 2019 Reproduction is authorised, provided the source is acknowledged. Please use for citation: authors, publication year, title, ISBN. Page | 2
Assessment of Needs for a European Strategy on Exposure Science ISES Europe 2018 Workshop Report Table of contents Acknowledgements ........................................................................................................ 4 Summary ..................................................................................................................... 5 1 Introduction .................................................................................................. 7 1.1 What is exposure science and how does it contribute to a healthy environment and to a safe and secure society? .............................................................................................. 7 1.2 Why is a European strategy and roadmap needed? .................................................... 8 2 Workshop Organization ................................................................................ 10 2.1 Workshop background and focus areas .................................................................. 10 2.2 Workshop Materials ............................................................................................. 11 3 Workshop Outcome ...................................................................................... 13 3.1 Exposure Science Trends ...................................................................................... 13 3.2 Exposure Science Strategic Analysis ...................................................................... 13 3.3 Needs Assessment .............................................................................................. 16 3.4 Established Building Blocks, Actions and Project Development .................................. 17 Data repositories and analytics ................................................................................ 18 Regulatory exposure assessment ............................................................................. 19 Building partnerships and collaboration ..................................................................... 21 Exposure data production and monitoring ................................................................. 22 Exposure assessment methods and tools .................................................................. 23 Exposure education and communication ................................................................... 24 4 Discussion and Conclusions ........................................................................... 26 References ................................................................................................................. 28 List of abbreviations and definitions ............................................................................... 31 List of figures .............................................................................................................. 32 List of tables ............................................................................................................... 32 Appendix A: Workshop Agenda ..................................................................................... 33 DAY 1: Tuesday, 19-June-2018 .................................................................................. 33 DAY 2: Wednesday, 20-June-2018 .............................................................................. 34 Appendix B: List of participants’ affiliations ..................................................................... 36 Appendix C: Session chairs, co-chairs, rapporteurs and moderators ................................... 38 Appendix D: SWOT analyses results of the thematic breakout sessions .............................. 40 Appendix E: List of Poster presented during the ISES Europe 2018 Workshop ..................... 46 Page | 3
Assessment of Needs for a European Strategy on Exposure Science ISES Europe 2018 Workshop Report Acknowledgements Sincere gratitude and appreciation go to the German Federal Institute for Occupational Safety and Health (BAuA) that hosted the first Workshop of the European Chapter of the International Society of Exposure Science (ISES Europe) on June 19-20, 2018 in Dortmund, Germany. We want to thank all the volunteers at BAuA and especially Dr. Rolf Packoff, Scientific Director of the Division ‘Hazardous Substances and Biological Agents’, Dr. Urs Schlüter, Head of Unit ‘Exposure Scenarios’, Melanie Berghaus, Unit ‘Exposure Scenarios’, and Elke Büdeker, Secretariat of ‘Hazardous Substances Management’ for arranging all logistics involved with the Workshop. In addition, ISES Europe wants to thank for the economic support of ECETOC, Cefic LRI, Eurometaux, BAuA, and the Swiss State Secretariat for Economic Affairs (Seco). ISES Europe is also grateful for the active participation and contribution of Dr. Claudia Cascio from the Evidence Management Unit of the European Food Safety Authority (EFSA) to the Workshop and to the present report. Finally, ISES Europe wants to express its gratitude to all workshop participants and their home institutions for their valuable inputs provided during the workshop. Assessing and combining all opinions expressed into a report of assessment needs for a European Strategy on Exposure Science and deriving recommendations has been a challenging, but rewarding task. This report represents a first and essential step for building and advancing the development of the strategy with a roadmap 2020-2030. Page | 4
Assessment of Needs for a European Strategy on Exposure Science ISES Europe 2018 Workshop Report Summary European legislations create unique demands for the European exposure science community. Human and environmental exposure assessments for chemicals are required as part of the risk assessments undertaken in the context of various legislations (e.g. under REACH, the Biocides Regulation, the General Food Law but also the Regulation on Medical Devices and Construction Products). In addition, regulations on general product safety, classification, labelling and packaging, control of air quality and major-accident hazards require input on exposure. Moreover, security-driven exposure assessments are being increasingly requested related to the misuse of chemical biological radiological and nuclear (CBRN) materials. Knowledge gaps, method and tool limitations, new needs together with longer-term EU strategies and several new trends all add additional challenges to the field of exposure science calling for the development of a European Strategy for Exposure Science. New trends that can be used as a starting point are for example: Exposure science offers much more enhanced knowledge and methods than is currently implemented in regulatory risk assessments. Further public rejection of using animals for safety testing of chemicals increases the dependency on exposure assessment. Growing appreciation of the importance of interactions between man and the environment in a globalised economy (e.g. green and/or circular economy, management of global supply chains and the contained chemicals, sustainability, biodiversity). Exposure to various chemicals at the same time and aggregate exposure to one chemical from different sources are increasingly recognised as requiring assessment, but neither the exposure data nor the assessment methods are available at present. As a first step of strategy building, the first workshop of the European Chapter of the International Society of Exposure Science (ISES Europe) took place on June 19-20, 2018 in Dortmund, Germany, hosted by the German Federal Institute for Occupational Safety and Health (BAuA). The main objectives of this workshop were: (1) to design the backbone of The European Exposure Science Strategy with a roadmap 2020-2030; (2) to create working groups with their own goals and agenda in alignment with the overall strategy; (3) to identify actions for further research and policy needs in Europe; and (4) to attract ISES Europe members committed to contributing to build the strategy and to increase the visibility of exposure science in Europe. The workshop was structured around six thematic areas that were identified on the basis of a stakeholder survey on needs for exposure science in Europe. These thematic areas were: 1. Data repositories and analytics, 2. Regulatory exposure assessment 3. Exposure data production and monitoring 4. Building partnerships and collaboration 5. Exposure assessment methods and tools 6. Exposure science education and communication On the first day, the focus was on assessing the needs, gaps and opportunities for exposure science in Europe, and on the second day, the focus was on identifying building blocks for fulfilling the identified needs. Both days started with keynote lectures and continued with thematic parallel working group sessions along the defined thematic areas. Page | 5
Assessment of Needs for a European Strategy on Exposure Science ISES Europe 2018 Workshop Report About 120 experts working at nine stakeholder groups participated in the workshop comprising European Commission Services, European Agencies, European Member States’ national authorities, industry, academia, consultants and insurance companies. During the breakout sessions, interactive discussions took place where exposure science practitioners discussed strategic activities and domains relevant for defining a strategy for exposure science to better serving human health and wellbeing, environmental safety needs, inform exposure policy domains, and help product developers and sustainability managers to achieve their goals towards a sustainable development in Europe. The workshop defined building blocks and actions, comprising e.g. the creation of working groups, and initiation of projects responding to the identified needs, concerning exposure science and relevant policies, and the level of coordination needed between the various stakeholders involved in the exposure science-policy interface. It was concluded that the following building blocks and actions are needed as a foundation of a European Exposure Science Strategy being: 1. To establish a common portal on exposure science, 2. To build a European exposure science network and partnerships, 3. To develop a common framework across policies and regulations making use of exposure science by focussing on the alignment of principles and efficiency enhancement, 4. To establish an integrated exposure assessment framework of methods and tools, and 5. To develop an education and training scheme. The present report summarises the workshop’s outcome and represents a first step towards the development of a European Exposure Science Strategy with a roadmap 2020-2030. The report is structured in a way that it first briefly introduces exposure science and its role for the European community (Chapter 1), followed by an overview of the first ISES Europe workshop organization (Chapter 2), the workshop outcome (Chapter 3), and a related brief discussion and some conclusions (Chapter 0). In the appendix, we provide the workshop agenda (Appendix A), a list of participants’ affiliations (Appendix B), names of session chairs, co-chairs, rapporteurs and moderators (Appendix C), the results of the SWOT analyses of the thematic breakout sessions (Appendix D), and a list of posters presented during the workshop (Appendix E). Page | 6
Assessment of Needs for a European Strategy on Exposure Science ISES Europe 2018 Workshop Report 1 Introduction 1.1 What is exposure science and how does it contribute to a healthy environment and to a safe and secure society? Exposure science aims to help understanding the mechanisms and extent to which humans or ecological receptors are exposed to stressors as well as understanding the situations posing a potential risk to human or environmental health. Stressors commonly refer to chemical, biological, radiological and nuclear (CBRN) agents or materials (European Commission, 2009; EU Centres of Excellence on CBRN, 2018), physical phenomena (noise), but also psychological and social phenomena (Senier et al., 2016). To address potential risks caused by these stressors, it is important to understand stressor related hazards (man-made and natural) that may lead to unwanted health and environmental effects while also addressing safety and security aspects (OECD, 2011), and sustainability aspects (OECD, 2011; Lioy and Smith, 2013). Both exposure and hazard assessments are indispensable parts of risk assessment and management strategies, and related analyses, such as impact assessments and socio-economic analyses (National Research Council, 2012). According to the European Chapter of the International Society of Exposure Science (ISES Europe), “Exposure Science” in its broadest sense studies 'the contact between stressors (primarily chemical, biological, and physical agents) and receptors (e.g. molecules, cells, organs, humans, other living organisms, and non-living items like buildings), and the associated pathways and processes potentially leading to negative effects on human health and the natural and built environment' (Bruinen de Bruin et al., 2019). In particular regarding chemicals, exposure science needs to integrate knowledge about their uses, i.e. the occurrence of substance in products and processes. Exposure science supports a better understanding of stressor-health relationships, but also provides choices to be made by stakeholders comprising scientists, citizens, policy-makers and exposure science practitioners in support of their work for a safer, more sustainable and more resilient society. It can speed up urgently needed changes in society including the transition towards affordable and clean energy and the implementation of many others of the United Nations’ Sustainable Development Goals (UN SDGs). Furthermore, it provides information related to impact assessments and the application of risk prevention measures due to potential deliberate misuse of CBRN materials and possible natural disasters. The availability of good quality and reliable exposure information is crucial. The current EU Regulation on chemicals management, REACH, created a mandate to deliver adequate exposure information to foster the safe use and management of chemicals (Regulation (EC) No 1907/2006). Exposure information is also required in a multitude of other European regulatory frameworks such as the General Food law, the Stockholm Convention on Persistent Organic Pollutants (Stockholm Convention on Persistent Organic Pollutants, 2009), the Rotterdam Convention on the promotion of shared responsibilities in relation to importation of hazardous chemicals (Rotterdam Convention, 2015), the Basle Convention on the Control of Transboundary Movements of Hazardous Wastes and Their Disposal (Basel Convention, 1995); the Seveso Directive on the control of major-accident hazards involving dangerous substances (Directive 2012/18/EU); Plant Protection Products Regulation (EC 1107/2009), Biocidal Products Regulation (EU No 528/2012); Protection of Workers Directive (2017/2398); Construction Products Regulation (EU No 305/2011); General Product Safety Directive (2001/95/EC); Classification, Labelling and Packaging Regulation (EC No 1272/2008); Page | 7
Assessment of Needs for a European Strategy on Exposure Science ISES Europe 2018 Workshop Report Medical Devices Regulation (EU 2017/745), Industrial Emissions Directive (2010/75/EU), Waste Framework Directive (2008/98/EC), and the Air Quality Directive (2008/50/EC). Furthermore, EU strategies to move towards a non-toxic environment by 2050 (Decision No 1386/2013/EU), to strive towards a bio-based and circular economy (European Commission, 2012 and 2015), as well as to promote green and sustainable chemistry all represent additional challenges requiring adequate exposure information. 1.2 Why is a European strategy and roadmap needed? Regulatory changes in the EU during the last decade increased the demand for high-quality exposure information in Europe more than elsewhere. However, in the case of insufficient or missing exposure information, default values and assumptions are frequently used. These are often not well underpinned, which can lead to incorrect risk estimates due to under- or overestimations of exposures and related risk, which hampers decision-making. Diverse parts of legislation put unique demands on the European exposure science community, such as knowledge gaps, method and tool limitations, new needs together with longer-term EU strategies and several new trends all add additional challenges to the field of exposure science. New trends that can be used as starting point are for example: Exposure science offers much more enhanced knowledge and methods than is currently recognised in regulatory risk assessments. Further public rejection of using animals for safety testing of chemicals increases the dependency on exposure assessment. Growing appreciation of the importance of interactions between man and the environment in a globalised economy (e.g. green and/or circular economy, management of global supply chains and the contained chemicals, sustainability, biodiversity). Exposure to various chemicals at the same time and aggregate exposure to one chemical from different sources are increasingly recognised as requiring assessment, but neither the exposure data nor the assessment methods are available at present. In Europe, exposure science is closely related to regulation, because a large part of exposure science is driven by regulatory needs. However, recent scientific advances face difficulties in finding their way into regulatory common practices. To address this issue in relation to European exposure science, professionals representing a wide range of stakeholders met and agreed that it was time to join forces and to work together building an urgently needed European Strategy for Exposure Science, and a related community. In 2017, ISES Europe was founded and strives to work out the best way to promote advancements of exposure science in Europe. Given the recent regulatory and non- regulatory developments, it is considered timely to ensure that exposure science is recognized by the European stakeholders as an independent field of science that requires specific advancements and harmonization across regulations and sectors. Multiple actors in the field expressed the need to have guidance to enhance transparency of choices made in the selection of exposure-related input data, and to better understand the representativeness and other quality aspects of monitoring data and model results. Further, substantiating the use of exposure science in health, safety and security-related regulatory actions requires stakeholders to collaborate on issues of outstanding importance, such as Page | 8
Assessment of Needs for a European Strategy on Exposure Science ISES Europe 2018 Workshop Report 1. Closing the most important gaps in knowledge (prioritized by their impact on human health and the environment), 2. Increasing efficiency and effectiveness of science organisation and management, 3. Development of education and training to broadly implement exposure science as an integral part of a safety/security culture at various levels including product development, safety and security of workplaces, emission minimisation from products, installations and services, etc. To formalize collaboration in support of addressing the above-listed challenges and goals, on June 19-20, 2018, ISES Europe organized a workshop involving European exposure science professionals from academia, industry, public stakeholder groups, insurance companies, and regulatory authorities (national and EU level). The overarching goal of the workshop was to assess the needs as a first step to develop a European strategy for promoting exposure science in support of public and environmental health research, safety and security practices and policy-making. Page | 9
Assessment of Needs for a European Strategy on Exposure Science ISES Europe 2018 Workshop Report 2 Workshop Organization 2.1 Workshop background and focus areas During the ISES 2016 Conference in Utrecht, The Netherlands, and prior to the ISES Europe workshop in Dortmund, Germany, two separate surveys were conducted targeting exposure science professionals that represent a wide spectrum of stakeholders. The first survey conducted in 2016 was sent to all participants (560) of the ISES 2016 Conference asking to indicate where exposure science should stand in five and 10 years, respectively. In addition, conference participants could indicate what their main drivers were to work in the field of exposure science and how a European chapter could contribute to better support a more efficient implementation of the exposure science work and uptake of related methods and results into policies. The second survey conducted in 2017 was sent to 720 European exposure science practitioners asking to provide ISES Europe with a top five priority on topics that are considered of key importance for shaping the Exposure Science in Europe until 2030. The outcomes of both surveys were pooled and categorised using text analysis software in addition to expert judgement. On this basis, six thematic exposure science focus areas were identified: 1. Data repositories and Analytics 2. Regulatory exposure assessment 3. Exposure data production and monitoring 4. Building partnerships and collaboration 5. Exposure assessment methods and tools 6. Exposure education and communication During the two-day workshop on June 19-20, 2018, two blocks of three parallel sessions across the aforementioned six thematic areas took place and discussed in breakout groups. Prior to these breakout sessions the working definition of exposure science drafted by the ISES Europe Board was presented and discussed. On the first day, focussing on each thematic exposure science area, the needs, gaps and opportunities for exposure science in Europe were assessed. The sessions of the second day aimed to identify the main building blocks which are essential to fulfil the identified needs as well as to identify actions including future research and policy needs, technologies, scientific support and methodologies. Both days started with keynote lectures of leading experts from the European Commission’s DG Environment, Shell/Ecetoc, University of Surrey and the Institute for Risk Assessment Sciences of the University of Utrecht, each providing a unique overview on exposure science from different perspectives. In total, 119 participants actively discussed the key needs and key building blocks required to develop a European Strategy for Exposure Science with a Roadmap 2020-2030. Page | 10
Assessment of Needs for a European Strategy on Exposure Science ISES Europe 2018 Workshop Report The strategic cycle of activities related to building and implementing a European Exposure Science Strategy is illustrated in Figure 1. The first ISES Europe workshop identified the needs and building blocks comprising working groups, actions and projects development. These results will feed into a second workshop with the aim to translate them into a concrete action plan entailing the prioritisation of needs, actions and project development with an indication of the timelines by which the needs should be fulfilled. Both the needs assessment and the action plan will shape the final content of the European Exposure Strategy with a roadmap 2020-2030. Based on this strategy, the stakeholders and working groups will work on a number of project implementations. The outcome of each project implementation will be assessed against its impact with regard to the enhancement of exposure science in Europe and will be made available in various forms (e.g. exposure guidelines and tools, databases, and trainings, etc.). Exposure Guidelines and Tools, Databases, Training Quality Control, Performance and Needs Assessment Impact Assessment Stakeholders and Working Group Action Project Plan implementation and resource allocation European Strategy with Roadmap 2020- 2030 Figure 1. The Strategic Cycle of activities for building and implementing a European Exposure Science Strategy. Throughout the workshop, participants were asked to think critically about the exposure science strategic analysis including assessment of the strengths, weaknesses, opportunities and threats (SWOT) for each of the six thematic exposure science areas. 2.2 Workshop Materials In the preparatory phase of the workshop, several documents and setups were developed to manage and streamline the discussions during the plenary and breakout sessions and to facilitate the reporting of intermediate and final results during and shortly after the workshop, respectively. Workshop Agenda: The workshop agenda is included in Appendix A. Page | 11
Assessment of Needs for a European Strategy on Exposure Science ISES Europe 2018 Workshop Report Workshop participating institutions: The institutions and companies that participated to the workshop are listed in Appendix B. Workshop organisation: Session chairs, co-chairs, and rapporteurs were approached by the ISES Europe board, and prepared the breakout groups assisted by an ISES Board Member acting as moderator of a breakout session (Appendix C). Workshop outcome: Summary of the SWOT (Strengths, Weaknesses, Opportunities and Threats) analysis, the Key Needs and Building Blocks for developing a European Exposure Science Strategy are included in Appendix D. Workshop posters: List of posters presented during the ISES Europe 2018 Workshop (Appendix E). Page | 12
Assessment of Needs for a European Strategy on Exposure Science ISES Europe 2018 Workshop Report 3 Workshop Outcome This chapter summarizes the results of the workshop. The following sections were developed using participants’ input, discussions, recorded notes and the completed summary tables as provided during the workshop. 3.1 Exposure Science Trends The European Strategy for Exposure Science should, amongst others, address the following topics that have a major impact on exposure science: 1. Exposure science elements are embedded in numerous documents of various European policy regulations and strategies demonstrating the importance and use of exposure science. However, despite its relevance, exposure science is often not recognised and acknowledged as an independent and self-standing scientific discipline. 2. Assessing of human and environmental health risks is currently recognised as requirement for an increasing number of stressors. Examples for which accurate assessment methods and data are currently lacking include chemical mixtures and aggregate exposures, 3. Low public awareness of possible risks from chemicals and other stressors. 4. Increasing acceptance by governments and their agencies of the concept of exposure-driven risk assessment for ensuring safety and security of the human population and the environment with decreasing dependency on use of animals testing. 5. Growing appreciation of the importance of interactions in a globalised economy between human health and the environment as well as anthropogenic impacts on the biosphere (green economy, sustainability, biodiversity, etc.). 6. Expansion of requests for and higher dependency on monitoring as such and by EU and global conventions and regulations (Stockholm Convention, Basel Convention, Rotterdam Convention, Minamata Convention, etc.). 7. Innovations in exposure assessment methodologies with application of cross-cutting assessment methodology. Exposure science offers much more knowledge and methods than is currently recognized by regulatory risk assessments. 8. Developing communication strategies and material to facilitate efficiency and transparency in sharing data, knowledge and harmonised method development. 3.2 Exposure Science Strategic Analysis A strategic analysis for exposure science and related scientific and policy fields was performed by identifying the strengths, weaknesses, threats and opportunities (SWOT). The results are tabulated and presented in Appendix D. In addition, a general SWOT diagram for exposure science was derived Page | 13
Assessment of Needs for a European Strategy on Exposure Science ISES Europe 2018 Workshop Report of the recurring themes identified across the individual parallel sessions of the Workshop. The results are summarised below. Strengths 1. Exposure science is multi-disciplinary and relies on and merges a multitude of different expertise such as environmental science, health sciences, consumer protection, security science and occupational safety. 2. Data sharing initiatives do exist including improved communication between various actors, data availability, and publicly accessible data platforms and evolving repositories. 3. Increase in exposure and risk-based regulations in Europe requires good use of exposure data in risk assessment practices. 4. A large number of tools useful for supporting exposure assessment practices is increasingly becoming available. 5. Increased support and improved understanding of the concentration burden and properties of chemicals and mixtures of chemicals in various media (environment, food and feed, products and indoor air human biomonitoring) through the data that are made available by the European Commission’s Information Platform for Chemical Monitoring (IPCHEM). 6. Emerging evolution of Exposome related research: initiating large multidisciplinary research programmes where the starting point is to assess the role of lifetime exposure to combined stressors regarding the human burden of disease. Research has strong focus on advancing the field with innovative technology, digitalisation, use of big data, etc. 7. Promising and recent advances in analytical methods that have provided new information on exposure to and related effects from previously unknown chemicals. 8. There are educational resources on various aspects of Exposure science available across Europe, however, they have not yet been consolidated via mainstream educational programmes (BSc, MSc and PhD level courses) Europe-wide. Weaknesses 1. Low profile of exposure science in Europe in regulatory, academic, industrial and supply chain circles, mainly due to (a) emphasis by regulatory bodies (concerned with chemicals and their human and environmental impacts) on hazard rather than risk and consequently, exposure data is not regarded as important, (b) few universities in Europe offer exposure science programmes and there are few if any dedicated academic Departments or Schools, and academic research is very limited, and (c) lack of or partial understanding of the overlapping with exposure science of the focus areas of other scientific disciplines which are better embedded into and accepted by regulatory, academic, industry and supply chain circles (e.g. e.g. occupational hygiene, human or environmental risk assessment or, environmental health, analytical chemistry, and forensic science). Page | 14
Assessment of Needs for a European Strategy on Exposure Science ISES Europe 2018 Workshop Report 2. Lack of a well-recognised set of standards for sampling, analyses, use of tools and data reporting, as reflected in the many publications underreport data or lack experimental details. 3. Absence of frameworks for exposure assessment in many regulatory guidelines (e.g. substances of unknown or variable composition, complex reaction products or biological materials (UVCB) and aggregate exposure). 4. Major deficiencies in the data on the uses and disposal of chemicals of interest from a human health and environmental perspective. 5. Major deficiencies for all aspects of training, research, definition of needs for non-chemical stressors. Opportunities 1. The development of ISES Europe enables a much stronger single voice for exposure science in Europe. 2. A common exposure quantification and assessment framework across regulations will stimulate data and methodologies sharing and transparency in their use. 3. Growing pressure on regulatory bodies to speed up the assessment of chemicals and to reassess old assessments based on quality data and exposure-based evidence. 4. Better involvement of and collaboration between European Commission Services and EU agencies is needed in exposure based assessments – e.g. on the UVCB substances 5. To date there are an increasing number of sample banks available that could provide opportunities for analysis of the history of sites of interest (e.g. in terms of pollution). 6. Increasing recognition that changes in human health and environment can be traced and quantified by the use of exposure indicators. 7. Advances in technologies applicable to exposure science and the interconnection of open access (big) data domains provide new opportunities for exposure research, monitoring and assessment. 8. In Europe concerns and risks of CBRN threats are increasing raising the question whether and how current methods and tools that are driven by safety can accommodate security and vulnerability-driven exposure and risk assessment. 9. Beneficial to integrate human health and the environment data (one health cloud) for streamlining assessments in regulations cross-cutting health and environment. 10. Creating mechanisms to combine development and application of different models and data across various domains and regulations. 11. ISES Europe could serve as a platform that provides expertise to create a suite of educational resources in exposure science from short introductory style courses to PhD level exposure science programmes. Page | 15
Assessment of Needs for a European Strategy on Exposure Science ISES Europe 2018 Workshop Report Threats 1. Many gaps on exposure science exist, hampering progress towards a sustainable development, including (a) overall exposure of humans and the environment to chemicals (in particular mixtures) and UVCB substances, (b) information on the use of chemicals (in products and articles) and the overall load of chemicals to the environment and to the technosphere, (c) failing regulatory implementation of environmental and human biomonitoring advances in the EU, and (d) estimation of releases from materials and articles, and proper quantification of low exposure levels. 2. Expectations arising from the development of ISES Europe cannot be met because of inadequate resources and/or the lack of availability of necessary expertise. 3. Assessments for regulatory purposes – like REACH - may become even more focussed on hazard alone. 4. Access to exposure studies may become even more limited because of commercial/confidential issues. 5. Dependence on black box tools may increase with the growth of artificial intelligence. 6. Harmonisation across the various disciplines that rely on exposure science may be strongly resisted or biased/political interpretation of exposure data may discredit exposure science. 7. Poor quality data/publications may undermine confidence in exposure science. 8. ‘Silo’ mentality between scientific disciplines and insufficient collaboration between disciplines and stakeholders. 3.3 Needs Assessment The SWOT analyses and discussions during the workshop related to the identification of key needs and building blocks of a European Exposure Science Strategy. The generic key needs identified across the six identified thematic areas are: 1) Identity: Defining the field of exposure science and finding an identity as exposure scientists; 2) Communication: establishing a long-term dialogue between disciplines within and outside exposure science; 3) Tools: Organization of tools, standardization, harmonization across disciplines within and linked to exposure science. As a result, the key building blocks should cover the following four exposure science domains and focus particularly on the following issues: Legislation and regulation regarding exposure assessment, material, facilities and activities: o Data storage Page | 16
Assessment of Needs for a European Strategy on Exposure Science ISES Europe 2018 Workshop Report o Standardisation and harmonisation where possible o Common framework for exposure science across regulatory schemes o Creation of incentives for sharing data and models o Respecting privacy, anonymity and intellectual property rights Exposure management tools, guidance, procedures and authorities o Transparency, reliability and uncertainty in regulatory exposure assessments o Coordination between and in-between stakeholders and EU and national agencies o Organisation of resources and development of business model to ensure sustainability and prevent collapse in case of resources unavailability o Better use and communication of the societal benefits of exposure science o Ensure a holistic approach comprising all types of exposure related aspects including social aspects, occupational, consumer and environmental exposures o Proper assessment of what is already available (no development of new instruments/tools before checking the applicability and suitability of what already exists) Assessment, detection, monitoring of exposure o Consolidated and robust methods to assess aggregate and combined (mixture) exposure o Methods to estimate releases from materials and products Collaboration, education and training o Creation of identity for exposure science as a scientific discipline which will deliver “exposure scientists” also in terms of a career pathway o Development of certified training and education establish exposure science as a professional discipline o Building strong alliances o Transparency in operating procedures and enhanced communication with relevant stakeholders 3.4 Established Building Blocks, Actions and Project Development After having identified needs and potential options, the participants discussed the required actions and building blocks to be conducted after the workshop. The following tables summarise the proposed building blocks, actions and ideas for project development for each of the six breakout groups. Page | 17
Assessment of Needs for a European Strategy on Exposure Science ISES Europe 2018 Workshop Report Data repositories and analytics A data repository is known as a data library or data archive that collect, manage, and store data sets for data analysis. The breakout group "Data repositories and analytics" considered that a virtual exposure platform would support the harmonisation of exposure assessments and help standardise data collection methods and procedures. Five possible working groups were identified each having a specific focus aiming at a better and more comparable use of models and data. The building blocks, actions and potential projects are listed in Table 1. Table 1. Proposed building blocks, actions and ideas for project development related to data repositories and analytics. Building blocks Actions Project development Platform/portal Establish a portal with: Inventory of portal needs a) Standardised model for data collection b) Data quality assurance c) Meta templates documentation d) Controlled vocabularies Working Groups Setting up Working Group on Mapping relevant models, data sources, exposure relevant Mapping determinants prioritising on harmonised/standardised/ widely used SOPs/templates in EU and beyond Setting up Working Group on Enable structured communication for each WG (Yammer, Extending data use wiki, SharePoint, etc.) Memorandum of understanding between involved stakeholders; transparency; scope, recognition of ownership, rights and responsibilities Setting up Working Group on Harmonisation (interoperability; control vocabularies, “Harmonisation” nomenclatures, data model and metadata templates Setting up Working Group on Data sharing principles/data provision incentives “Interoperability” IT technologies, distributed systems, platforms Setting up Working Group on “Quality Setting up QC/QA procedures Assurance” Page | 18
Assessment of Needs for a European Strategy on Exposure Science ISES Europe 2018 Workshop Report Regulatory exposure assessment Exposure assessment is subject to regulatory requirements that are defined by each sort and area of regulation. Although the end result may be similar, like it is safe, or not safe, or it poses a risk, or the risk is acceptable, the way how to come to the result commonly differs. Amongst other factors, this depends on differences in terminology throughout EU policies and on the use and documentation of data and models. The breakout group "Regulatory exposure assessment" considered that the establishment of a common framework focusing on efficiency enhancement across policies using exposure sciences is key. This framework should characterize the needs in exposure science across regulations and promote harmonisation of terms, vocabulary, templates for model documentation throughout the EU -legislation. Furthermore, three working groups were identified, each of which has a specific focus with regard to assessment method aspects and communication. The building blocks, actions and potential projects are listed in Table 2. Table 2. Proposed building blocks, actions and ideas for project development related to regulatory exposure assessment. Building blocks Actions Project development Common Organisation of common framework Harmonisation of terms and vocabulary throughout EU- framework of focusing on efficiency enhancement legislation (ISES to provide starting point for regulatory across policies using exposure implementation in existing legislation) exposure sciences assessment Harmonised template for model documentation and science across the reporting; Common framework for model acceptance different Characterisation of differences in exposure science needs regulatory across regulations frameworks with relevant exposure Harmonisation of models across and within regulations evaluation Development of a more common understanding how safety assessment under REACH and work place risk assessment/management under OSH could work together Working Groups Setting up Working Groups on Rules and guidance for uncertainty analysis and examples “transparency/ reliability/ uncertainty” how to address uncertainties in decision making Criteria or scoring system for reliability of measured and modelled data Transparency in assessments to better share knowledge and methods Read-across of available data Guidance to identify and describe contextual information for exposure information and data (e.g. measurement method, use information, duration …) Setting up Working Group on “Model Further develop models/methods for mixtures, release development”* from articles and aggregate exposure Ensure development of tools until their regulatory readiness, including validation, user-interface and transparent documentation Page | 19
Assessment of Needs for a European Strategy on Exposure Science ISES Europe 2018 Workshop Report Develop guidance on what tool/model to use in different situations ensuring the complexity for being used in regulatory context is at acceptable level Setting up a business model ensuring long-term maintenance of models Setting up Working Group on Acceptance of risk levels based on quantitative exposure “Communication” data Improvements in supply chain communication on uses, use-conditions and related exposure Improving exposure scenarios beyond use descriptors resulting in higher usefulness for practical risk management Influence the EU-framework project agenda Regulatory harmonisation and acceptance Success stories and 30 seconds messages Establish communication channels between different stakeholders (industry, decision-makers, grant holders, academic, risk assessors and disseminators) *also suggested by breakout group “Exposure assessment and tools” Page | 20
Assessment of Needs for a European Strategy on Exposure Science ISES Europe 2018 Workshop Report Building partnerships and collaboration Forming partnerships and relationships with other stakeholders dealing with exposure science can be vital to the success of each stakeholder. Success can be measured or expressed in different ways including efficiency enhancement, cost saving, shared burden, etc. In order to achieve success, stakeholders must be open to collaborate and share not only within their own institute or company, but also between institutions and companies. The breakout group "Building partnerships and collaboration" identified the building of European Partnerships as key. These partnerships will promote the creation and development of European networks in Exposure science enhancing multidisciplinary collaboration promoting synergies between scientists from different disciplines, policy-makers, practitioners and citizens. These networks will exchange information relevant for the development, identification, promotion and exchange of best practices, education and training, and raising awareness of the added value of exposure science. One working group was identified that could support the building of European networks. The building blocks, actions and potential projects are listed in Table 3. Table 3. Proposed building blocks, actions and ideas for project development related to building partnerships and collaboration. Building blocks Actions Project development European Building Partnerships to promote the Networking among key stakeholders and key networks creation and development of groups/projects, like HEAdhoc, REEG groups, and European networks and related HBM4EU activities in Exposure science Development, identification, promotion and exchange of best practices Provide technical and capacity development support to each other Preparation, development and implementation of education and training modules and tools aiming to increase multidisciplinary collaboration Raising awareness of the added value of exposure science Promoting synergies between science, health, regulator, consumers Working Group Setting up Working Group on Making inventory of stakeholders from the Workshop’s “Partnerships” participants Making inventory of individuals who can provide links to stakeholders (e.g., people with current memberships of other societies) Creation of success stories representing who we are and what we can offer (guidelines, best practices, movies), featuring different success stories for different stakeholders Page | 21
Assessment of Needs for a European Strategy on Exposure Science ISES Europe 2018 Workshop Report Exposure data production and monitoring Exposure data production and monitoring is very important not only to comply with regulations, but moreover to provide safety and security to workers, consumers and the environment. Exposure data production is essential for exposure management that aims at the elimination of hazardous sources, at improvement of the production processes and products. This is made possible (among others) by data production and monitoring. Data production and monitoring (and collection) allows for the analysis of the potentially exposure-related causes of various phenomena in any period of time, current exposure assessment and forecasting future exposures. The breakout group "Exposure data production and monitoring" identified the creation of a handbook of best practices as key to covering all aspects of exposure science including exposure scenarios, the collection of standardization and harmonization efforts and a quality rating tool for data and models. One working group or a project was proposed regarding a database for exposure factors in Europe. The identified building blocks, actions and potential projects are listed in Table 4. Table 4. Proposed building blocks, actions and ideas for project development related to exposure data production and monitoring. Building blocks Actions Project development Handbook of best The long-term aim would be to Start with mapping what is there practice develop of a handbook of best Separate by exposure science related fields, collect practices covering all aspects of standards/harmonisation efforts in these fields exposure science including data production and monitoring. Define which contextual information should be available in connection with samples For this purpose, a Working Group on “Common standards in Develop quality rating scheme (Q-factors like in ConsExpo safety and security-driven fact sheets?) exposure data production and monitoring” may be established. Working Group A working group or a project on “A Revitalisation of European exposure factor collection data base for exposure factors in including Europe” (building on national a. Definition of needs, hosting and quality handbooks, JRC ExpoFacts or requirements ConsExpo Fact sheets) b. Use of existing formats, like ConsExpo fact sheets or OECD harmonised template OHT301 c. Setting up a Committee that derives standard default values in specific areas d. Preparation of and requesting funding for a COST action project Page | 22
Assessment of Needs for a European Strategy on Exposure Science ISES Europe 2018 Workshop Report Exposure assessment methods and tools Exposure assessment methods and tools largely drive the outcome of exposure assessment. One could use good data, but apply an inappropriate method and produce an inaccurate exposure assessment. Furthermore, a method that is adequate to use for one regulatory purpose may not necessarily be an appropriate method to be used within the frame of a different regulatory framework. The breakout group "Exposure assessment methods and tools" identified the establishment of integrated frameworks for the assessment of multiple (aggregate, cumulative, mixture) exposures as key. Integrated frameworks should function on the basis of multi-tier tools and models can constitute the starting point for building a common exposure science framework across policy domains based on harmonising and building consistency in used data and models. One working group was identified that could establish the landscape regarding user information. The building blocks, actions and potential projects are listed in Table 5. Table 5. Proposed building blocks, actions and ideas for project development related to exposure assessment methods and tools. Building block Actions Project development Integrated Develop integrated frameworks Map multiple different stressors (chemical mixtures) and framework(s) for exposure assessment over the different regulatory domains (aggregate exposure) Evaluate REFIT effort results Creating consistent integrated multi-tier tools Identify main contributors (e.g. associations) Define common exposure aspects across regulations Develop/align methods with emerging toxicity data and models (e.g. in-vitro testing) Establish linkages with common framework of regulatory exposure assessment science and the development of the IT platform/portal Working Groups Setting up Working Group on Inventory existing information tools/templates ”User information” Identify user needs across domains Harmonisation of vocabulary/results reports Define limits, scope, applicability domain, etc. across available methods and tools Build common, consistent structures to inform users about exposure methods and tools Setting up Working Group on Identification of (applicability) gaps and inform on needs ”Model evaluation”* for new data generation Develop methods for evaluation of models Define uncertainty factors for default values *also suggested by breakout group “Regulatory exposure assessment” Page | 23
Assessment of Needs for a European Strategy on Exposure Science ISES Europe 2018 Workshop Report Exposure education and communication In the past, exposure assessments were typically only concerned with external exposure to chemicals. Today, the concept of what is embraced by exposure assessment has changed. It is now recognised that: • it is the internal exposure that should be the connection between toxicology and exposure assessment. This implies the examination of toxicokinetics and absorption processes; • Exposure science should embrace exposure to non-chemical stressors (biological and physical); • Exposure to combinations of stressors requires much greater emphasis. This recognition emphasizes the need for an initiative to develop postgraduate exposure science training in order to address the lack of sufficient expertise in exposure assessment. In the past, risk assessments often only gave limited attention to exposure assessment but, with a growing interest in health screening, and ever-increasing domains for which risk assessments are required, a new risk assessment paradigm, centred on exposure assessment has become vital. The breakout group "Exposure education and communication" proposed that ISES Europe should take up the role of communicator and trainer supporting the development of a tiered education/training scheme with ECTS equivalent points/credits. One working group was identified that should explore possibilities along these lines. The building blocks, actions and potential projects are listed in Table 6. Table 6. Proposed building blocks, actions and ideas for project development related to exposure education and communication Building block Actions Project development Foundation of ISES Develop a certified tiered ISES Description of type of course (Short term – online course, Europe as a Europe approach to ES education Intermediate term – specialised workshops, Long term communicator and with ECTS (European Credit goal – postgraduate course) trainer. Transfer System) equivalent Identify possible cost actions to fund course/programme points/credits development and delivery Identify potential sources of funding from industry Working Group Setting up Working Group on Propose short courses during conferences (e.g. SETAC Working Group/Advisory panel pre-conference 1-day short courses) on "Exposure Science Education, Seek participation from all relevant stakeholders Training and Communication" including representatives of ISES Europe, Industry, Policy- makers, Academia, Insurers, and other Professional Societies Provide a list of the identified academic programmes on the ISES Europe website (informative – not accredited). Explore potential role of ISES as a training course approver or accrediting body Define EES career paths that reflect career options within each stakeholder group, publish on the ISES website Creation of a Syllabus on Exposure Science understand stakeholder needs and requirements for education/training Page | 24
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